Implant with fiducial markers

ABSTRACT

An implant can include a flexible body made of a non-bioresorbable hydrogel material. The implant can also include a radiopaque marker located within the flexible body, where the body and the radiopaque marker can be implanted in a body cavity to mark the cavity in a radiographic image of the cavity.

CLAIM OF PRIORITY

This patent application claims the benefit of priority, under 35 U.S.C.Section 119(e), to Simmons U.S. Patent Application Ser. No. 62/911,682,entitled “ BIORESORBABLE IMPLANT WITH FIDUCIAL MARKERS,” filed on Oct.7, 2019, which is hereby incorporated by reference herein in itsentirety.

BACKGROUND

Patients with breast cancer may elect to undergo treatment to treat thelump or tumor. Treatment options include a mastectomy, a lumpectomy,radiation, and chemotherapy depending on several factors, such as sizeand location of the tumor. In some cases, patients may undergo multipletreatments to improve likelihood of survival. For example, a patient mayundergo a lumpectomy procedure, followed by focused radiation therapy.It may also be desirable to monitor tissue of the breast at or near thesurgical site, such as at a cavity or void created by removal of atumor.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 illustrates a front view of a lumpectomy procedure, in accordancewith at least one example of this disclosure.

FIG. 2 illustrates a top view of an implant, in accordance with at leastone example of this disclosure.

FIG. 3 illustrates a top view of an implant, in accordance with at leastone example of this disclosure.

FIG. 4 illustrates a front view of a cavity filled with an implant, inaccordance with at least one example of this disclosure.

FIG. 5A illustrates a front view of an implant, in accordance with atleast one example of this disclosure.

FIG. 5B illustrates a front view of an implant, in accordance with atleast one example of this disclosure.

FIG. 5C illustrates a cross-sectional view of an implant, in accordancewith at least one example of this disclosure.

FIG. 5D illustrates a cross-sectional view of an implant, in accordancewith at least one example of this disclosure.

FIG. 6A illustrates a front view of an implant, in accordance with atleast one example of this disclosure.

FIG. 6B illustrates a front view of a cavity filled with an implant, inaccordance with at least one example of this disclosure.

FIG. 6C illustrates a front view of an implant, in accordance with atleast one example of this disclosure.

FIG. 6D illustrates a front view of a cavity filled with an implant, inaccordance with at least one example of this disclosure.

FIG. 6E illustrates a front view of a cavity filled with an implant, inaccordance with at least one example of this disclosure.

FIG. 7A illustrates a front view of a lumpectomy procedure, inaccordance with at least one example of this disclosure.

FIG. 7B illustrates a side view of a lumpectomy procedure, in accordancewith at least one example of this disclosure.

FIG. 7C illustrates a perspective view of an implant assembly, inaccordance with at least one example of this disclosure.

DETAILED DESCRIPTION

In a lumpectomy operation, a tumor or cancerous mass can be removed froma breast of a patient, such as by creating an incision to access thetumor. The tumor can be resected, such as by using a scalpel, from thesurrounding healthy breast tissue. Some surrounding breast tissue canalso be resected to create a margin around the tumor. The combinedtissue and tumor resections can create a cavity in the breast tissue.

This cavity can be a target for future radiation therapy where radiationcan be directed at the cavity to treat any cancer cells that may remainfollowing resection of the tumor. Implants can be used to demark thecavity for radiographic image guided radiation therapy. That is, animplant can be implanted in the cavity, where the implant can includeportions made of radiopaque materials (materials with a relatively highradiodensity). The radiopaque materials can operate as fiducials toguide the radiation therapy. However, some implants can be relativelyrigid, which can be palpable to the patient, which can increase patientanxiety. Further, relatively rigid implants can make a patientuncomfortable. Moreover, relatively rigid structures that arebioresorbable can break into many parts, which can be sharp, furthercreating patient discomfort.

This disclosure can help to address these problems by providing animplant that is relatively flexible. The implant can be generally shapedlike a ribbon and can include a fiducial (radiopaque) marker extendingalong a length of the ribbon. The implant can be configured to be packedinto the cavity to fill the cavity, which can help keep the cavity opento improve aesthetics of the breast and can help promote fluid intakeinto the cavity to help permanently fill the cavity. Also, because theribbon can be relatively flexible, the implant can be used to fillcavities having irregular shapes. Such flexibility of the ribbon canalso allow for the implant to have a reduced palpability, helping toreduce patient anxiety and patient comfort. The flexibility can alsoreduce a possibility of breaking of the implant into sharp pieces, whichcan further help improve patient comfort.

In some examples, the ribbon can be bioresorbable such that the fiducial(radiopaque wire) can be left behind after resorption of the ribbon,allowing detection of the cavity following resorption. Further, becausethe ribbon can have a relatively small thickness, the ribbon can beresorbed by the body in a relatively small period of time. Also, theimplant can be provided at one or more lengths, such that the implantcan be trimmed to a desired length depending on a size of the cavity.

The above discussion is intended to provide an overview of subjectmatter of the present patent application. It is not intended to providean exclusive or exhaustive explanation of the invention. The descriptionbelow is included to provide further information about the presentpatent application.

FIG. 1 illustrates a front view of a lumpectomy operation, in accordancewith at least one example of this disclosure. FIG. 1 shows a humanbreast 50, an incision. 52, a tumor (54A and 54B), and a cavity 56.

In one example, it may be desired to remove the tumor 54A from withinthe breast 50. In a lumpectomy operation to remove the tumor 54A, theincision 52 can be created on the breast 50, such as by using a scalpel.Using the incision 52 to access the tumor 54B, the tumor 54B can beresected and removed from the breast 50. Before or during removal of thetumor 54 from the breast 50, some surrounding breast tissue can also beresected to create a margin around the tumor 54. Removal of the tumor54B from the breast 50 (and margin creation) can create the cavity 56within the breast 50. The cavity 56 can be a target for future radiationtherapy where radiation can be directed at the cavity 56 to treat anycancerous (or pre-cancerous) cells that may remain following resectionand removal of the tumor 54B. It can be helpful to fill the cavity 56with a fiducial or marker to act as a radiopaque target for futureradiation therapy of the cavity 56 and the surrounding area.

FIG. 2 illustrates a top view of an implant 200, in accordance with atleast one example of this disclosure. The implant 200 can include aribbon 202, and a wire 204.

The implant 200 can generally be an implant configured for implantationinto a human body, such as the cavity 56 of the breast 50 of FIG. 1. Theimplant 200 can be comprised of biocompatible materials, as discussedbelow in further detail. The ribbon 202 of the implant 200 can be agenerally flexible elongate body 203 that can be comprised of abioresorbable material (can be configured to be broken down and absorbedby a human body). In some examples, the ribbon 202 can be comprised ofone or more of a collagen, a glycosaminoglycan, a starch, a silk, analginate, a chitin, a chitosan, a polylactic acid, a polyglycolic acid,a polyanhydride, a polycaprolactone, a poly(hydroxbutyrate), apoly(hydroxyvalerate), or the like. The ribbon 202 can have one or morelayers of the same material or of different materials.

FIG. 2 shows a length L of the implant 200, a width W of the implant200, and a thickness t of the implant 200. The dimensions of the implant200 can generally be configured for implantation into a cavity, such asthe cavity 56 of the breast 50 of FIG. 1. For example, the width W canbe smaller than the length L and the thickness t can be smaller than thewidth such that the ribbon 202 is generally long, thin, and flexible. Insome examples, the width W can be between 0.1 centimeters and 5centimeters. In some examples, the width W can be between 1 centimeterand 3 centimeters. In some examples, the thickness t can be between 0.01millimeters and 10 millimeters. In some examples, the thickness can bebetween 0.05 millimeters and 3 millimeters. Because the ribbon 202 canhave a relatively small thickness t, the ribbon 202 can be configured tobe resorbed by the body in a relatively small period of time.

The wire 204 can generally be a long thin wire configured forimplantation into a cavity. The wire 240 can be connected to the ribbon202 and can extend along the length L of the ribbon 202. In someexamples, the wire 204 can be connected to the ribbon 202 via abioresorbable adhesive. In some examples, the wire 204 can be woventhrough the ribbon 202. The wire 204 can be attached to the ribbon 202in other ways, such as through the use of fasteners, or the like.

The wire 204 can undulate along the length L of the ribbon in someexamples, (such as along a sine wave pattern). In other examples, thewire 204 can be straight along the length L (or substantially straight).As shown in FIG. 2, the wire can extend along an entirety of the lengthL of the ribbon 202. However, in other examples, the wire 204 can extendalong only a portion of the length L of the ribbon 202 or can besegmented along the length L of the ribbon 202.

The wire 204 can be made of biocompatible and radiopaque materials suchas one or more of titanium, titanium alloys, polyether ether ketone, astainless-steel alloy, a cobalt-chromium alloy, or the like. The wire204 can be configured to act as a fiducial or marker for the cavity,such as by being a radiopaque wire visible in radiographic images tomark the cavity after implantation of the implant 200. Further, the wire204 can act as a fiducial or marker in radiographic images and afterresorption of the ribbon 202. Because the ribbon 202 can bebioresorbable, the wire can operate as a fiducial or marker afterresorption of the ribbon 202, allowing detection of the cavity followingresorption of the ribbon 202.

FIG. 3 illustrates a top view of an implant 300, in accordance with atleast one example of this disclosure. The implant 300 can include aribbon 302 and a wire 304. The ribbon 302 can include strands 306defining openings 308. Also shown in FIG. 3 is a cutting instrument 60.

The implant 300 can be similar to the implant 200 discussed above,except that the ribbon 302 of the implant 300 can be a mesh. The mesh ofthe ribbon 302 can be made of the strands 306 which can beinterconnected to each other and can define openings 308 between thestrands 306. The mesh can be of a simple pattern, such as a woven crosspattern, or the like. In some examples, the mesh can have an intricatepattern defining oval openings, hexagonal openings, octagonal openings,or the like. In some examples, the ribbon 302 can be a non-woven mesh (abody including evenly spaced openings).

FIG. 3 also shows that the implant 300 can be trimmed. For example,during a procedure, an implant having a length L can be selected forimplantation.

In one example, the length L can be 50 centimeters. During a procedure,it may be determined that the 50 centimeters length is too long. Theimplant 300 can be trimmed using the cutting instrument 60, which can bea pair of scissors, to achieve a desired length of the implant 300, suchas 30 centimeters. In some examples, the length L can be trimmed priorto the procedure. In further examples, the implant 300 can be providedin a large roll and the implant 300 can be cut to a desired length.

The length L can be between 10 centimeters and 10 meters in someexamples. The length L can be between 10 centimeters and 1 meter in someexamples.

FIG. 4 illustrates a front view of a cavity 70 filled with an implant400, in accordance with at least one example of this disclosure. Theimplant 400 can include a ribbon 402, a wire 404, a first ribbon end406, a second ribbon end 408, a first wire end 410, and a second wireend 412. FIG. 4 also shows the cavity 70 having a volume V.

The implant 400 can be similar to the implants 100 or 200 discussedabove; however, FIG. 4 shows the implant 400 following insertion intothe cavity 70. The implant 400 can be inserted into the cavity usingvarious procedures. In one such example, the implant 400 can be selectedto have an implant length based on a size of the cavity 70, such as thevolume V of the cavity 70. Then, the implant 400 can be trimmed, ifdesired, based on the volume V of the cavity 70 (similar to the processshown in FIG. 3).

The implant 400 can then be inserted into the cavity 70 (for exampleusing forceps and/or by hand) and can be packed to fill (or at leastpartially fill) the volume V of the cavity. In some examples, excessportions of the implant 400 can be trimmed following insertion of theimplant 400 into the cavity. Following the procedure, an image of thecavity can be acquired, where the image shows the radiopaque wire 404 ofthe implant within the cavity 70, such that the wire 404 can demark thecavity 70. Following imaging, radiation can be directed at the wire 404to deliver radiation to the cavity 70.

In some examples, the cavity 70 can have an irregular shape, as shown inFIG. 4. Because the ribbon 402 and the wire 404 are relatively flexible,the implant 400 can be packed into the cavity 70 to substantially(practically) fill the volume V of the cavity 70. Filling of the cavity70 with the implant 400 can help keep the cavity open post-operativelyto help reduce breast indentations, which can improve aesthetics of thebreast following the lumpectomy procedure. Keeping the cavity 70 openpost-operatively can also help promote fluid intake into the cavity 70to help promote healing and tissue ingrowth to help permanently fill thecavity 70 (following resorption of the ribbon 402).

Also, because the ribbon 402 and the wire 404 are relatively flexible,the implant 400 can help to reduce palpability of the implant 400,helping to reduce patient anxiety. Also, because the ribbon 402 and theradiopaque wire 404 are configured to flex within the cavity afterimplantation, the implant 400 can flex or move within the cavity (afterimplantation) in response to forces applied to the cavity. This can helpreduce a painful interaction between the implant 400 and surroundingbreast tissue.

In some examples, the first end 406 of the ribbon 402 and the first end410 of the wire 404 can be configured to move with respect to the secondend 408 of the ribbon 402 and the second end 412 of the wire 404 withinthe cavity 70 (after implantation) in response to forces applied to thecavity 70. This can help reduce a painful interaction between theimplant 400 and surrounding breast tissue. In some examples, the firstend of the wire 410 and/or the second end of the wire 412 can be roundedor capped to decrease sharpness of the ends 410 and 412 of the wire,which can further help decrease patient discomfort.

FIG. 5A illustrates a front view of an implant 500A, in accordance withat least one example of this disclosure. The implant 500A can include aribbon 502, a first wire 504, and second wires 506.

The implant 500A can be similar to the implants discussed above, exceptthat the implant 500A can include the second wires 506, which can beconnected to the ribbon 502 and can extend along a width W of anelongate body (the ribbon 502), where the second wires 506 can beoriented substantially orthogonal to the first wire 504. Each of thefirst wire 504 and the second wires 506 can be radiopaque. Though fiveof second wires 506 are shown in FIG. 5A, more or less can be used, suchas 1, 2, 3, 4, 6, 7, 8, 9, 10, 15, 20, or the like second wires. In someexamples, the second wires 506 can be spaced every half centimeter, evercentimeter, every two centimeters, or the like.

FIG. 5B illustrates a front view of an implant 500B, in accordance withat least one example of this disclosure. The implant 500B can include aribbon 502, a first wire 504 a and a second wire 504 b.

The implant 500B can be similar to the implants discussed above, exceptthat the implant 500B can include the first wire 504 a and the secondwire 504 b, where each of the first wire 504 a and the second wire 504 bcan be connected to the ribbon 502 and can extend along a length L of anelongate body 503 of the ribbon 502. The wires 504 can each berelatively straight along the length L of the ribbon 502. The secondwire 504 b can be substantially parallel to the first wire 504 a. Thoughtwo wires 504 are shown in FIG. 5B, more wires can be used, such as 3,4, 5, 6, 7, 8, 9, 10, 15, 20, or the like wires.

FIG. 5C illustrates a cross-sectional view of an implant 500C, inaccordance with at least one example of this disclosure. The implant500C can include a body 502 and a wire 504. Also shown in FIG. 5C is adiameter d of the wire 504.

The implant 500C can be similar to those discussed above, except thatthe body 502 can be a bioresorbable layer surrounding the wire 504. Theshape of the implant 500C can help to fill relatively larger cavities.In some examples, the diameter d of the wire 504 can be between 0.01millimeters and 5 millimeters. In some examples, the diameter d of thewire 504 can be between 0.05 millimeters and 2 millimeters.

FIG. 5D illustrates a cross-sectional view of an implant 500D, inaccordance with at least one example of this disclosure. The implant500D can include a body 502 and a wire 504. The body 502 can includearms 508 a-508 d (collectively referred to as arms 508).

The implant 5001) can be similar to the implant 500C discussed above,except that the body 502 can have a cross-sectional shape of a plus oran X, where the arms 508 can extend radially outward from the wire 504.The shape of the implant 500D can help to fill relatively largercavities, while the arms 508 can have a relatively small thickness,which can help to reduce a time required for resorption of the body 502.

Though the implants 100-500 discussed above are discussed as beingconfigured for implantation into a cavity of a breast, the implants canbe configured for implantation into any cavity to act as a fiducial ormarker for the purposes of imaging and/or targeted radiation therapy.For example, the implants can be configured for implantation into bone.

Though wires 104-504 are discussed as being wires, the fiducial elementscan have other elongate radiopaque shapes, such as a ribbon shape(rectangular prism), a triangular prism shape, a hexagonal prism shape,an octagonal prism shape, or the like. In some examples the wires104-504 can be of a single strand. In other examples, the wires can bemade of multiple woven strands. In some examples, the wires 104-504 canbe of a single extruded piece. In other examples, the wires 104-504 canbe made of several connected pieces (or several disconnected pieces).

In some examples, the wire can be of the shape of multiple disconnectedloops where each loop has no ends. That is, a plurality of wires in theshape of loops can be connected to the body of the ribbon, which canreduce sharp ends of the radiopaque wire, and can simplify removal ofthe wires, when such a procedure is necessary.

Any of the ribbons 200, 300, 400, or 500 or methods regarding suchribbons discussed above can be used in any procedure where a surgicalprocedure leaves a crater, dent, divot, or recessed cavity in the bodysuch as the removal of tumors, cysts, lipomas, or dermoid cysts, or thelike.

FIG. 6A illustrates a front view of an implant 600, in accordance withat least one example of this disclosure. The implant 600 can include abody 602 and a marker 604. The body 602 can be formed of a hydrogel 603,as discussed in further detail below. FIG. 6B shows the implant 600 in acavity 70. FIGS. 6A and 6B are discussed together below.

The implant 600 can generally be an implant configured for implantationinto a human body, such as the cavity 56 of the breast 50 of FIG. 1 orthe cavity 70 of FIG. 6B. However, the implant 600 can be implantableinto cavities in a variety of locations in a body. The hydrogel 603 thatforms the body 602 (or most of the body 602) can be made ofbiocompatible materials, such as a non-bioabsorbable (ornon-bioresorbable) hydrogel. The hydrogel 603 can be one or more of ahomopolymer, a copolymer, a semi-interpenetrating network, aninterpenetrating network, and a self-assembling peptide system. Thehydrogel 603 can be radiolucent for observation or identification of theradiopaque markers 604.

The hydrogel can be degradable or non-degradable and can be a natural orsynthetic polymer network that is hydrophilic and can absorb a highamount of water. The hydrogel can be a solid or porous hydrogel/polymerand can be made from any non-biodegradable polymer. A non-biodegradablepolymer having mechanical properties that can be controlled separatelyby varying the polymer concentration and/or the method of polymerizationcan be used, including one or more of polyvinyl pyrrolidone,polyacrylamide, polyethylene glycol, or polyurethane. In some examples,polyvinyl alcohol (PVA) can be used. The hydrogel modulus properties canbe controlled separately by varying polymer and water concentrations ora method of gelation such as freezing and thawing. In its dehydratedform, a solid hydrogel can change in shape, size, and stiffnessproviding shelf-life stability. Upon rehydration, the hydrogel can swellto its full size.

The body 602 of the implant 602 can be a generally flexible memberhaving a shape of a sphere. The body 602 can have other shapes in otherexamples, such as an ovoid, an oblate spheroid, a prolate spheroid, acube, a dodecahedron, a icosahedron, or the like. Use of a rounded shapecan help to reduce palpability of the implant 600 following implantationin a breast cavity. The body 602 can be non-bioabsorbable such that theimplant 600 can fill a volume v of the breast cavity 70 following thelumpectomy to help maintain the shape of the of the breast following thelumpectomy.

The marker 604 can be made of biocompatible and radiopaque materialssuch as one or more of titanium, titanium alloys, polyether etherketone, a stainless-steel alloy, a cobalt-chromium alloy, or the like.The marker 604 can have a spherical shape and can be configured to actas a fiducial or marker for the cavity, such as by being radiopaque(visible in radiographic images) to mark the cavity after implantationof the implant 600. The marker 604 can be in a fixed location within thebody 602 or can be free to move within the body 602.

As shown in FIG. 6B, the body 602 and the radiopaque marker 604 togethercan be configured to fill at least a portion of the cavity 70 to helpfill the cavity 70 after implantation. Once implanted within the cavity70, the body 602 and the radiopaque marker 604 can move together withrespect to the cavity 70 or with the cavity. The hydrogel 603 forming atleast a portion of the body 602 can be made of a hydrogel having amodulus of elasticity similar to a modulus of elasticity of humansubcutaneous breast tissue. For example, the modulus of elasticity ofthe hydrogel 603 can be between 0.5 and 25 kilopascals. The modulus ofelasticity of the hydrogel 603 can be between 5 and 20 kilopascals. Themodulus of elasticity of the hydrogel 603 can be between 10 and 15kilopascals. By using a hydrogel with qualities similar to that of humanbreast tissue, discomfort caused by the implant 600 can be reduced andpalpability of the implant 600 can be reduced.

FIG. 6B also shows an outer layer 605 of the body 602 that can be adehydrated layer of hydrogel. Following implantation of the implant 600into the cavity 70, the dehydrated layer 605 can absorb liquid (theliquid can be of the cavity 70 or inserted therein) to expand within thecavity 70. Such expansion of the outer layer 605 and therefore theimplant 600 can help to create a hemostatic environment, which can helpto reduce bleeding or hematomas within the cavity 70.

FIG. 6C illustrates a front view of an implant 600, in accordance withat least one example of this disclosure. The implant 600 can be similarto the implant of FIGS. 6A and 6B; FIG. 6C shows that the implant 600can include multiple markers 604 and can include markers of variousshapes. For example, a marker 604 a can have a dumbbell shape, a marker604 b can have a coil shape, a helix shape, or a compression springshape, and the marker 604 c can have a ovoid shape. The marker 604 canbe of other shapes in other examples.

In some examples, markers within each implant can have a unique shape toallow for individual tracking of implants following implantation. Forexample, a kit can be provided including several implants, where eachimplant has a marker in the shape of a number, a letter, or anothershape unique to the kit or set of implants.

FIG. 6D illustrates a front view of the cavity 70 filled with implants610, in accordance with at least one example of this disclosure. Theimplant 610 can be similar to the implant 600 discussed above, where theimplant 610 can be relatively smaller than the implant 600, as discussedin further detail below. The implant 610 can include a body 612 ofhydrogel 613 and a marker 614, which can be similar to the body 602, thehydrogel 603, and the marker 604 of the implant 600, respectively.

By using the implant 610 that has a size that is relatively smaller thanthe implant 600 with respect to the cavity 70, the implants 610 a, 610b, 610 c, 610 d, 610 e, and 610 f can be used to fill the cavity 70 andto help match a shape and volume of the cavity 70. Use of multipleimplants 610 can also allow the implants 610 to move easier within thecavity 70 which can allow the implants to maintain the shape of thecavity 70 as the surrounding tissue moves.

FIG. 6E illustrates a front view of the cavity 70 filled with theimplant 600 and the implants 610. FIG. 6E shows that the implant 600 canhave a diameter D1 that can be larger than a diameter D2 of the implants610. By using one of the implant 600 and multiple of the implants 610,the cavity 70 can be relatively quickly filled by the implant 600 andthe irregular shape of the cavity 70 can be filled by the implants 610a-610 c allowing relatively few implants to be used while thecombination of implants can still conform to the shape of, or fill, thecavity 70. FIG. 6E also shows that one or more of the implants 600 and610 can include multiple markers 604 a and 604 b, which can help todistinguish types of implants following implantation.

FIG. 7A illustrates a front view of a lumpectomy procedure, inaccordance with at least one example of this disclosure. FIG. 7Billustrates a side view of a lumpectomy procedure, in accordance with atleast one example of this disclosure. FIGS. 7A and 7B are discussedtogether below.

FIGS. 7A and 7B show a human breast 50 and a cavity 56. FIGS. 7A and 7Balso show an inserter assembly 700 and implants 610 a, 610 b, and 610 c.

The implants 610 can be similar to the implants 600 and 610 discussedabove. The inserter assembly 700 can include an introducer 702, whichcan be an elongate tube that can be flexible or can be rigid. Theintroducer 702 can be configured to extend from a cavity to external tothe tissue, as discussed below. The introducer 702 can be made of one ormore of polymers, metals, or the like. The inserter assembly 700 canoptionally include multiple introducers with multiple internal diametersfor insertion of implants of varying diameters. In some examples, theintroducer 702 can have an internal diameter sufficiently large toaccommodate insertion of implants of every size included in an assemblyor kit of implants (e.g., implants 600 and 610).

In operation of some examples, an incision 72 can be created around anareola 74 of the breast 50 for removal of the tumor. The incision can belocated at any other location of the breast. Following removal of thetumor, the implants 610 can be placed into the cavity 70 by hand, forexample, when the cavity 56 is near the incision 72. When the cavity 56is distant from the incision, such as shown in FIGS. 7A and 7B, or whenthe cavity 56 is tunneled, the introducer 702 can be used to insert theimplants 610. A biocompatible surgical lubricant can optionally beapplied to an external surface of the introducer 702 to reduce frictionbetween the introducer 702 and breast tissue. A biocompatible surgicallubricant can also optionally be, applied to an internal surface of theintroducer 702 (such as via injection) to reduce friction between theintroducer 702 and implants 610 during insertion of the implants 610.

Following lubrication, the introducer 702 can be inserted through theincision 72 until it reaches the cavity 56. The implants 610 can beinserted into a proximal end of the introducer 702 where each of theimplants 610 can be guided by the introducer 702 into the cavity 56. Theimplants 610 can be added, for example one at a time, until the cavityis filled or is sufficiently filled, as determined by a surgeon.

FIG. 7C shows that the implant assembly 700 can include a stylet 704,which can be a rigid or semi-rigid elongate member. FIG. 7C also showsthat the introducer can include a proximal opening 706 and the distalopening 708.

The stylet can have an outer diameter smaller than an inner diameter ofthe introducer 702 such that the stylet 704 can be inserted into aproximal opening 706 of the introducer 702 and the stylet 704 can beextended into the introducer 702 along a length of the introducer 702.The stylet 704 can include a blunt end 710 configured to engageimplants, such as the implants 610 a and 610 b within the introducer702. In some examples, the stylet 704 can have a length that is longerthan a length of the introducer 702.

During operation, following insertion of the introducer 702, it may bedesired to guide the implants 610 a and 610 b into the cavity 56 throughthe introducer, such as if the implants 610 a and 610 h cease movingthrough the introducer 702 via the force of gravity alone. The stylet704 can be inserted into the proximal opening 706 of the introducer 702to engage the implants 610 a and 610 b with the blunt end 710 of thestylet 704 to urge or three the implants 610 distally through theintroducer 702, out of the distal opening 708, and into the cavity 56.Following placement of the implants 610 within the cavity, theintroducer 702 and the stylet 704 can be removed from the cavity 56 andincision 72 and the openings can be closed in standard surgical fashion.

Though the methods and systems herein are discussed above with respectto lumpectomies performed in human breasts, the implants, systems, andmethods can be used in any other procedure where a surgical procedureleaves a crater, dent, divot, or recessed cavity in the body such as theremoval of tumors, cysts, lipomas, or dermoid cysts, or the like.

NOTES AND EXAMPLES

The following, non-limiting examples, detail certain aspects of thepresent subject matter to solve the challenges and provide the benefitsdiscussed herein, among others.

Example 1 is an implant comprising: a ribbon defining a flexibleelongate body, the ribbon comprised of a bioresorbable material; and aradiopaque wire connected to the ribbon and extending along a length ofthe ribbon, the ribbon and the radiopaque wire configured forimplantation in a body cavity to mark the cavity in a radiographic imageof the cavity.

In Example 2, the subject matter of Example 1 optionally includeswherein the radiopaque wire is configured to be visible in theradiographic image to mark the cavity in the radiographic image of thecavity after implantation of the implant and after resorption of theribbon.

In Example 3, the subject matter of any one or more of Examples 1-2optionally include wherein the ribbon and the radiopaque wire areconfigured to move together with respect to the cavity and within thecavity after implantation.

In Example 4, the subject matter of Example 3 optionally includeswherein a first end of the ribbon and a first end of the radiopaque wireare configured to move with respect to a second end of the ribbon and asecond end of the radiopaque wire within the cavity after implantationin response to forces applied to the cavity.

In Example 5, the subject matter of any one or more of Examples 1-4optionally include wherein the ribbon and the radiopaque wire togetherare configured to fill at least a portion of the cavity to hold thecavity open after implantation.

In Example 6, the subject matter of any one or more of Examples 1-5optionally include wherein the ribbon and the radiopaque wire togetherare positionable to fill the cavity when the cavity has an irregularshape.

In Example 7, the subject matter of any one or more of Examples 1-6optionally include a second radiopaque wire connected to the ribbon andextending along the length of the ribbon, the second radiopaque wiresubstantially parallel to the radiopaque wire.

In Example 8, the subject matter of any one or more of Examples 1-7optionally include a second radiopaque wire connected to the ribbon andextending along a width of the ribbon, the second radiopaque wiresubstantially orthogonal to the radiopaque wire.

In Example 9, the subject matter of any one or more of Examples 1-8optionally include wherein the ribbon is a mesh.

In Example 10, the subject matter of any one or more of Examples 1-9optionally include wherein the ribbon defines a width smaller than thelength, and a thickness smaller than the width.

In Example 11, the subject matter of Example 10 optionally includeswherein the width is between 0.1 centimeters and 3 centimeters.

In Example 12, the subject matter of Example 11 optionally includeswherein a diameter of the radiopaque wire is between 0.05 millimetersand 3 millimeters.

In Example 13, the subject matter of any one or more of Examples 1-12optionally include wherein the radiopaque wire is comprised of titanium,polyether ether ketone, a stainless-steel alloy, and a cobalt chromiumalloy, or a combination thereof.

In Example 14, the subject matter of any one or more of Examples 1-13optionally include wherein the ribbon is comprised of a collagen, aglycosaminoglycan, a starch, a silk, an alginate, a chitin, a chitosan,a polylactic acid, a polyglycolic acid, a polyanhydride, apolycaprolactone, a poly(hydroxbutyrate), a poly(hydroxyvalerate), or acombination thereof.

In Example 15, the subject matter of any one or more of Examples 1-14optionally include wherein the radiopaque wire extends along an entiretyof the length of the ribbon.

Example 16 is a method of implanting a marker comprising: selecting animplant length based on a size of a cavity; and inserting the implantinto the cavity to at least partially fill the cavity, the implantincluding a ribbon defining a flexible elongate body comprised of abioresorbable material, and the implant including a radiopaque wireconnected to the ribbon and extending along a length of the ribbon.

In Example 17, the subject matter of Example 16 optionally includesacquiring a radiographic image of the cavity showing the radiopaque wirewithin the cavity.

In Example 18, the subject matter of any one or more of Examples 16-17optionally include directing radiation at the radiopaque wire to deliverradiation to the cavity.

In Example 19, the subject matter of any one or more of Examples 16-18optionally include positioning the implant within the cavity tosubstantially fill a volume of the cavity.

In Example 20, the subject matter of Example 19 optionally includeswherein the cavity has an irregular shape.

In Example 21, the subject matter of any one or more of Examples 16-20optionally include wherein the radiopaque wire is configured to bevisible in a radiographic image to mark the cavity after implantation ofthe implant and after resorption of the ribbon.

In Example 22, the subject matter of any one or more of Examples 16-21optionally include wherein the ribbon and the radiopaque wire areconfigured to flex within the cavity after implantation.

Example 23 is a method of implanting a marker comprising: trimming alength of the implant; and inserting the implant into a cavity to atleast partially fill the cavity, the implant including a ribbon defininga flexible elongate body comprised of a bioresorbable material, and theimplant including a radiopaque wire connected to the ribbon andextending along a length of the ribbon.

In Example 24, the subject matter of Example 23 optionally includesselecting the implant length based on a size of a cavity prior totrimming the length.

In Example 25, the subject matter of any one or more of Examples 23-24optionally include acquiring a radiographic image of the cavity showingthe radiopaque wire within the cavity.

In Example 26, the subject matter of any one or more of Examples 23-25optionally include directing radiation at the radiopaque wire to deliverradiation to the cavity.

In Example 27, the subject matter of any one or more of Examples 23-26optionally include positioning the implant within the cavity tosubstantially fill a volume of the cavity.

Example 28 is an implant comprising: a flexible elongate body, the bodycomprised of a bioresorbable material; and a radiopaque wire connectedto the body and extending along a length of the body, the body and theradiopaque wire configured for implantation in a body cavity to mark thecavity in a radiographic image of the cavity.

In Example 29, the subject matter of Example 28 optionally includeswherein the radiopaque wire is configured to be visible in theradiographic image to mark the cavity in the radiographic image of thecavity after implantation of the implant and after resorption of thebody.

In Example 30, the subject matter of Example 29 optionally includeswherein the body and the radiopaque wire are configured to move togetherwith respect to the cavity and within the cavity after implantation.

In Example 31, the subject matter of Example 30 optionally includeswherein a first end of the body and a first end of the radiopaque wireare configured to move with respect to a second end of the body and asecond end of the radiopaque wire within the cavity after implantationin response to forces applied to the cavity.

In Example 32, the subject matter of any one or more of Examples 29-31optionally include wherein the body and the radiopaque wire together areconfigured to fill at least a portion of the cavity to hold the cavityopen after implantation.

In Example 33, the subject matter of any one or more of Examples 29-32optionally include wherein the body and the radiopaque wire together arepositionable to fill the cavity when the cavity has an irregular shape.

In Example 34, the subject matter of any one or more of Examples 29-33optionally include a second radiopaque wire connected to the body andextending along the length of the body, the second radiopaque wiresubstantially parallel to the radiopaque wire.

In Example 35, the subject matter of any one or more of Examples 29-34optionally include a second radiopaque wire connected to the body andextending along a width of the body, the second radiopaque wiresubstantially orthogonal to the radiopaque wire.

In Example 36, the subject matter of any one or more of Examples 29-35optionally include wherein the body is a mesh.

In Example 37, the subject matter of any one or more of Examples 29-36optionally include wherein the body defines a width smaller than thelength, and a thickness smaller than the width.

In Example 38, the subject matter of Example 37 optionally includeswherein the width is between 0.1 centimeters and 3 centimeters.

In Example 39, the subject matter of Example 38 optionally includeswherein a diameter of the radiopaque wire is between 0.05 millimetersand 3 millimeters.

In Example 40, the subject matter of any one or more of Examples 29-39optionally include wherein the radiopaque wire is comprised of titanium,polyether ether ketone, a stainless-steel alloy, and a cobalt chromiumalloy, or a combination thereof.

In Example 41, the subject matter of any one or more of Examples 29-40optionally include wherein the ribbon is comprised of a collagen, aglycosaminoglycan, a starch, a silk, an alginate, a chitin, a chitosan,a polylactic acid, a polyglycolic acid, a polyanhydride, apolycaprolactone, a poly(hydroxbutyrate), a poly(hydroxyvalerate), or acombination thereof.

In Example 42, the subject matter of any one or more of Examples 29-41optionally include wherein the body is cylindrical.

In Example 43, the subject matter of any one or more of Examples 29-42optionally include wherein the body has cross sectional X shape.

Example 44 is an implant comprising: a flexible body made of anon-bioresorbable hydrogel material; and a radiopaque marker locatedwithin the flexible body, the body and the radiopaque marker configuredfor implantation in a body cavity to mark the cavity in a radiographicimage of the cavity.

In Example 45, the subject matter of Example 44 optionally includeswherein the radiopaque marker is configured to be visible in theradiographic image to mark the cavity in the radiographic image of thecavity after implantation of the implant.

In Example 46, the subject matter of any one or more of Examples 44-45optionally include wherein the flexible body and the radiopaque markerare configured to move together with respect to the cavity and withinthe cavity after implantation.

In Example 47, the subject matter of any one or more of Examples 44-46optionally include wherein the flexible body and the radiopaque markertogether are configured to fill at least a portion of the cavity to holdthe cavity open after implantation.

In Example 48, the subject matter of any one or more of Examples 44-47optionally include wherein the flexible body has a geometric shape of asphere.

In Example 49, the subject matter of any one or more of Examples 44-48optionally include wherein the flexible body is made of a hydrogelhaving a modulus of elasticity similar to a modulus of elasticity ofhuman subcutaneous breast tissue.

In Example 50, the subject matter of Example 49 optionally includeswherein a modulus of elasticity of the hydrogel of the first body andthe second body is between 0.5 and 25 kilopascals.

In Example 51, the subject matter of any one or more of Examples 44-50optionally include wherein the radiopaque marker is made of titanium,polyether ether ketone, a stainless-steel alloy, and a cobalt chromiumalloy, or a combination thereof.

In Example 52, the subject matter of any one or more of Examples 44-51optionally include a second radiopaque marker located within theflexible body, the second radiopaque marker, together with the flexiblebody and the radiopaque marker, configured for implantation in the bodycavity to mark the cavity in a radiographic image of the cavity.

Example 53 is an implant assembly comprising: a first implantcomprising: a first body made of a flexible and non-bioresorbablehydrogel material, the first body having a shape of a sphere defining afirst diameter; and a first marker located within the first body, thefirst marker made of a radiopaque material, and the first body and thefirst marker configured for implantation in a body cavity to mark thecavity in a radiographic image of the cavity; and a second implantcomprising: a second body made of the flexible and non-bioresorbablehydrogel material, the second body having a shape of a sphere defining asecond diameter different from the first diameter; and a second markerlocated within the second body, the second marker made of a radiopaquematerial, and the second body and the second marker configured forimplantation in the body cavity to mark the cavity in a radiographicimage of the cavity.

In Example 54, the subject matter of Example 53 optionally includeswherein the second diameter is smaller than the first diameter.

In Example 55, the subject matter of any one or more of Examples 53-54optionally include wherein the second diameter is less than half of thefirst diameter.

In Example 56, the subject matter of any one or more of Examples 53-55optionally include wherein the first implant and the second implant arepositionable to fill the cavity when the cavity has an irregular shape.

In Example 57, the subject matter of any one or more of Examples 53-56optionally include wherein the modulus of elasticity of the hydrogel ofthe first body and the second body is between 0.5 and 25 kilopascals.

In Example 58, the subject matter of any one or more of Examples 53-57optionally include wherein the first body and the second body havegeometric shapes of spheres.

Example 59 is an implant assembly comprising: a plurality of firstimplants, each of the first implants comprising: a first body made of aflexible and non-bioresorbable hydrogel material, the first body havinga shape of a sphere defining a first diameter; and a first markerlocated within the first body, the first marker made of a radiopaquematerial, and the first body and the first marker configured forimplantation in a body cavity to mark the cavity in a radiographic imageof the cavity; and a plurality of second implants, each of the secondimplants comprising: a second body made of the flexible andnon-bioresorbable hydrogel material, the second body having a shape of asphere defining a second diameter different from the first diameter; anda second marker located within the second body, the second marker madeof a radiopaque material, and the second body and the second markerconfigured for implantation in the body cavity to mark the cavity in aradiographic image of the cavity.

In Example 60, the subject matter of Example 59 optionally includeswherein a quantity of first implants and a quantity of second implantsis selectable to fill the cavity when the cavity has an irregular shape.

In Example 61, the subject matter of Example 60 optionally includeswherein the second diameter is smaller than the first diameter.

In Example 62, the subject matter of any one or more of Examples 60-61optionally include wherein the second diameter is less than half of thefirst diameter.

In Example 63, the subject matter of any one or more of Examples 59-62optionally include wherein a modulus of elasticity of the hydrogel ofthe first body and the second body is between 0.5 and 25 kilopascals.

Example 64 is an implant assembly comprising: an implant selectable froma plurality of implants, the implant comprising: a body made of aflexible and non-bioresorbable hydrogel, the body having a shape of asphere; and a marker located within the body, the marker made of aradiopaque material, and the body and the marker configured forimplantation in a breast cavity to mark the cavity in a radiographicimage of the cavity; and an introducer comprising an elongate tubeinsertable into the breast cavity and configured to receive the implanttherethrough to guide the implant into the breast cavity.

In Example 65, the subject matter of Example 64 optionally includes astylet insertable into the introducer and configured to engage theimplant to position the implant within the breast cavity.

In Example 66, the subject matter of Example 65 optionally includeswherein the stylet has a length that is longer than a length of theintroducer.

In Example 67, the subject matter of any one or more of Examples 65-66optionally include wherein the plurality of implants each have a shapeof a sphere.

In Example 68, the subject matter of Example 67 optionally includeswherein a first quantity of the plurality of implants define a firstdiameter and wherein a second quantity of the plurality of implantsdefine a second diameter that is smaller than the first diameter.

In Example 69, the subject matter of any one or more of Examples 64-68optionally include wherein the body is made of a hydrogel having amodulus of elasticity similar to a modulus of elasticity of humansubcutaneous breast tissue.

In Example 70, the subject matter of any one or more of Examples 64-69optionally include a dehydrated hydrogel layer located on and connectedto an exterior surface of the body, the dehydrated hydrogel layerconfigured to expand within the breast cavity upon implantation thereof.

Example 71 is an implant comprising: a flexible body made of anon-bioresorbable hydrogel material; and a radiopaque marker located atleast partially within the flexible body, the body and the radiopaquemarker to mark a body cavity in a radiographic image of the cavityfollowing implantation of the implant within in the body cavity.

In Example 72, the subject matter of Example 71 optionally includeswherein the radiopaque marker radiographically marks the cavity afterimplantation of the implant.

In Example 73, the subject matter of any one or more of Examples 71-72optionally include wherein the flexible body and the radiopaque markerare configured to move together with respect to the cavity and withinthe cavity after implantation.

In Example 74, the subject matter of any one or more of Examples 71-73optionally include wherein the flexible body hearing the radiopaquemarker is dimensioned to fill at least a portion of the cavity.

In Example 75, the subject matter of any one or more of Examples 71-74optionally include wherein the flexible body has a geometric shape of asphere.

In Example 76, the subject matter of any one or more of Examples 71-75optionally include wherein the flexible body is made of a hydrogelhaving a modulus of elasticity similar to a modulus of elasticity ofhuman subcutaneous breast tissue.

In Example 77, the subject matter of Example 76 optionally includeswherein the modulus of elasticity of the hydrogel of the flexible bodyis between 0.5 and 25 kilopascals.

In Example 78, the subject matter of any one or more of Examples 71-77optionally include wherein the radiopaque marker is made of titanium,polyether ether ketone, a stainless-steel alloy, and a cobalt chromiumalloy, or a combination thereof.

In Example 79, the subject matter of any one or more of Examples 71-78optionally include a second radiopaque marker located within theflexible body, the second radiopaque marker, together with the flexiblebody and the radiopaque marker, to mark the body cavity in aradiographic image of the cavity following implantation of the implantwithin the body cavity.

Example 80 is an implant assembly comprising: a first implantcomprising: a first body made of a flexible and non-bioresorbablehydrogel material, the first body having a first shape; and a firstmarker located at least partially within the first body, the firstmarker made of a radiopaque material, and the first body and the firstmarker implantable in a body cavity to mark the cavity in a radiographicimage of the cavity; and a second implant comprising: a second body madeof the flexible and non-bioresorbable hydrogel material, the second bodyhaving a second shape; and a second marker located at least partiallywithin the second body, the second marker made of a radiopaque material,and the second body and the second marker implantable in the body cavityto mark the cavity in a radiographic image of the cavity, wherein thefirst shape and the second shape are the same shape or are differentshapes, and wherein the first shape and the second shape are the samesize or are different sizes.

In Example 81, the subject matter of Example 80 optionally includeswherein the first body and the second body have geometric shapes ofspheres and wherein the first body defines a first diameter and thesecond body defines a second diameter.

In Example 82, the subject matter of Example 81 optionally includeswherein the second diameter is smaller than the first diameter.

In Example 83, the subject matter of any one or more of Examples 81-82optionally include wherein the second diameter is less than half of thefirst diameter.

In Example 84, the subject matter of any one or more of Examples 80-83optionally include wherein the first implant and the second implant arepositionable to fill the cavity when the cavity has an irregular shape.

In Example 85, the subject matter of any one or more of Examples 80-84optionally include wherein the modulus of elasticity of the hydrogel ofthe first body and the second body is between 0.5 and 25 kilopascals.

Example 86 is an implant assembly comprising: an implant comprising oneor more selectable implant bodies, the implant comprising: an implantbody made of a flexible and non-bioresorbable hydrogel; and a markerlocated within the implant body, the marker made of a radiopaquematerial, the implant body bearing the marker being implantable in abreast cavity to mark the cavity in a radiographic image of the cavity;and an introducer comprising an elongate tube insertable into a bodycavity and operable to receive the implant body therethrough to guidethe implant body into the body cavity.

In Example 87, the subject matter of Example 86 optionally includes astylet insertable into the introducer and operable to engage the implantto position the implant body within the body cavity.

In Example 88, the subject matter of Example 87 optionally includeswherein the stylet has a length that is longer than a length of theintroducer.

In Example 89, the subject matter of any one or more of Examples 86-88optionally include wherein the implant comprises a plurality of implantbodies selectable from the plurality of implant bodies, wherein a firstquantity of the plurality of implant bodies define a first diameter andwherein a second quantity of the implant bodies define a second diameterthat is smaller than the first diameter.

In Example 90, the subject matter of any one or more of Examples 86-89optionally include a dehydrated hydrogel layer located on and connectedto an exterior surface of the implant body, the dehydrated hydrogellayer to expand within the body cavity following implantation thereof.

Example 91 is a method of implanting a plurality of implants in a bodycavity, the method comprising: selecting an implant from a plurality ofimplants, the implant including a body made of a flexible andnon-bioresorbable hydrogel and including a radiopaque marker located atleast partially within the body; inserting an introducer defining anelongate tube into the body cavity; and inserting the implant into thebody cavity using the introducer.

In Example 92, the subject matter of Example 91 optionally includesinserting a stylet into the introducer to engage the implant to positionthe implant within the body cavity.

In Example 93, the subject matter of any one or more of Examples 91-92optionally include selecting a second implant from the plurality ofimplants; and inserting the second implant into the body cavity usingthe introducer.

In Example 94, the subject matter of Example 93 optionally includeswherein the first implant and the second implant are of different sizes.

In Example 95, the subject matter of any one or more of Examples 93-94optionally include wherein the first implant and the second implant arespheres having different diameters.

In Example 96, the apparatuses or method of any one or any combinationof Examples 1-95 can optionally be configured such that all elements oroptions recited are available to use or select from.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” in thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

The invention claimed is:
 1. An implant assembly comprising: a firstimplant comprising: a first body made of a flexible andnon-bioresorbable hydrogel material, the first body having a firstshape; and a first marker located at least partially within the firstbody, the first marker made of a radiopaque material, and the first bodyand the first marker implantable in a body cavity to mark the cavity ina radiographic image of the cavity; and a second implant comprising: asecond body made of the flexible and non-bioresorbable hydrogelmaterial, the second body having a second shape; and a second markerlocated at least partially within the second body, the second markermade of a radiopaque material, and the second body and the second markerimplantable in the body cavity to mark the cavity in a radiographicimage of the cavity, wherein the first shape and the second shape arethe same shape or are different shapes, wherein the first shape and thesecond shape are the same size or are different sizes, wherein the firstbody and the second body have geometric shapes of spheres and whereinthe first body defines a first diameter and the second body defines asecond diameter, and wherein the second diameter is smaller than thefirst diameter.
 2. The implant assembly of claim 1, wherein the seconddiameter is less than half of the first diameter.
 3. The implantassembly of claim 1, wherein the first implant and the second implantare positionable to fill the cavity when the cavity has an irregularshape.
 4. The implant assembly of claim 1, wherein a modulus ofelasticity of the hydrogel of the first body and the second body isbetween 0.5 and 25 kilopascals.
 5. An implant assembly comprising: animplant comprising one or more selectable implant bodies, the implantcomprising: an implant body made of a flexible and non-bioresorbablehydrogel; and a marker located within the implant body, the marker madeof a radiopaque material, the implant body bearing the marker beingimplantable in a breast cavity to mark the cavity in a radiographicimage of the cavity; and an introducer comprising an elongate tubeinsertable into a body cavity and operable to receive the implant bodytherethrough to guide the implant body into the body cavity; wherein theimplant comprises a plurality of implant bodies selectable from theplurality of implant bodies, wherein a first quantity of the pluralityof implant bodies define a first diameter and wherein a second quantityof the implant bodies define a second diameter that is smaller than thefirst diameter.
 6. The implant assembly of claim 5, further comprising:a stylet insertable into the introducer and operable to engage theimplant to position the implant body within the body cavity.
 7. Theimplant assembly of claim 6, wherein the stylet has a length that islonger than a length of the introducer.
 8. The implant of claim 5,further comprising: a dehydrated hydrogel layer located on and connectedto an exterior surface of the implant body, the dehydrated hydrogellayer to expand within the body cavity following implantation thereof.9. An implant assembly comprising: a first implant comprising: a firstbody made of a flexible and non-bioresorbable hydrogel material, thefirst body having a first shape, and the first body defining a firstdiameter; and a first marker located at least partially within the firstbody, the first marker made of a radiopaque material, and the first bodyand the first marker implantable in a body cavity to mark the cavity ina radiographic image of the cavity; and a second implant comprising: asecond body made of the flexible and non-bioresorbable hydrogelmaterial, the second body having a second shape, the first body and thesecond body having geometric shapes of spheres, and the second bodydefining a second diameter that is smaller than the first diameter; anda second marker located at least partially within the second body, thesecond marker made of a radiopaque material, and the second body and thesecond marker implantable in the body cavity to mark the cavity in aradiographic image of the cavity.
 10. The implant assembly of claim 9,wherein the second diameter is less than half of the first diameter. 11.The implant assembly of claim 9, wherein the first implant and thesecond implant are positionable to fill the cavity when the cavity hasan irregular shape.
 12. The implant assembly of claim 9, wherein amodulus of elasticity of the hydrogel of the first body and the secondbody is between 0.5 and 25 kilopascals.